Skip to content

Sonographic Diaphragm Function in AECOPD

Ultrasound of the Diaphragm As Physiological Biomarker in Acute Exacerbations of Chronic Obstructive Pulmonary Disease

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05671198
Acronym
UNDATED
Enrollment
51
Registered
2023-01-04
Start date
2023-03-27
Completion date
2025-08-31
Last updated
2024-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Copd

Keywords

diaphragm, COPD, thoracic ultrasound

Brief summary

The study will be conducted as a single-center, prospective cohort study. The primary objective of this study is to investigate the responsiveness of sonographic parameters of diaphragm to detect change in Borg score for dyspnea during hospitalisation for AECOPD without respiratory acidosis.

Detailed description

To investigate the responsiveness of sonographic parameters to detect change in Borg score for dyspnea during hospitalisation for AECOPD without respiratory acidosis, we propose a prospective cohort design. After inclusion, participants will have assessment of diaphragm function (excursion, thickness, thickening fraction) using ultrasound within 48 hours of admission to the emergency ward, striving to assessment within 24 hours of admission. Additionally, dyspnea grade will be assessed using validated questionnaires. Further diagnostic work-up and treatment for AECOPD is performed at the discretion of the treating physician. Both ultrasound measurements and dyspnea grade questionnaires will be repeated when the participant is reported suitable for hospital discharge by the treating physician.

Interventions

Sonographic parameters of the diaphragm: * Thickening Fraction (TF); (Diaphragm thickness end-inspiration- Diaphragm thickness end-expiration) / Diaphragm thickness end-expiration. (continuous variable). * Diaphragm end-expiratory thickness: Diaphragm thickness at end-expiration (continuous variable) * Diaphragm excursion (DE): diaphragm inspiratory amplitude during deep breathing (continuous variable).

Sponsors

Isala
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Hospitalisation primarily because of severe acute exacerbation of COPD * COPD, according to GOLD 2018 definition * Post-bronchodilator FEV1/FVC \< 0,70 and FEV1% \< 80%pred. within last 5 years

Exclusion criteria

* Respiratory acidosis (pH \< 7.35 ánd PaCO2 \> 6 kPA) * Need for (non-)invasive ventilation based on other criteria (e.g. severe hypoxia) upon presentation. * Established diagnosis of diaphragm diaphragm paralysis. * Inability for diaphragm imaging (e.g. mechanical ventilation, or unable to follow vocal instructions). * Those not able or unwilling to give written informed consent. * Pregnant women

Design outcomes

Primary

MeasureTime frameDescription
- To investigate the responsiveness of sonographic parameters to detect change in Borg score for dyspnea during hospitalisation for AECOPD without respiratory acidosis.from admission till hospital discharge (expected median of 5 days based on experience)Correlation between: * Change in Borg score for dyspnea; defined as score at discharge minus score at admission * Change in sonographic parameters; defined as score at discharge minus score at admission

Countries

Netherlands

Contacts

Primary Contactwytze s de Boer, m.d.
w.s.de.boer@isala.nl00316463120231

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026